Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02076893
Eligibility Criteria:
Inclusion Criteria:
* Child must be scheduled to undergo tonsillectomy (with or without adenoidectomy)
* Child must be between the ages of 4 and 15 at the time of enrollment.
* Child and caregiver must be English-speaking
* The same caregiver (e.g., mother) must agree to complete all study assessments with child to ensure consistency
Exclusion Criteria:
* Child cannot self-assess pain due to conditions such as developmental delays, chromosomal abnormalities, or other syndromes
* Child had significant adverse effects to tramadol, gabapentin and/or ibuprofen in the past
* Child has a known underlying seizure disorder (not febrile seizure)
* Child has known underlying renal or liver dysfunction (with creatinine, aspartate aminotransferase /alanine aminotransferase, more than twice above normal value for age, respectively)
* Child is taking an selective serotonin reuptake inhibitor (SSRI), norepinephrine reuptake inhibitor (SNRI), monoamine oxidase inhibitor (MAOI) or tricyclic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
15 Years
Study:
NCT02076893
Study Brief:
Protocol Section:
NCT02076893